Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD

NCT06823063 | Not Yet Recruiting Phase 1

• 1 other identifier: LC-MSC-ILD21003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease. To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).

Conditions

CTD-ILD

Outcome Measures

Primary Outcomes (2)

• AE

  Adverse events and serious adverse events.

  1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks

• Forced Vital Capacity（FVC）

  Absolute change in FVC

  24 weeks

Secondary Outcomes (9)

• Forced Expiratory Volume in One Second (FEV1)

  12 weeks, 24 weeks

• Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

  12 weeks, 24 weeks

• St. George's Respiratory Questionnaire (SGRQ）

  12 weeks, 24 weeks

• Short Form Health Survey (SF-36)

  12 weeks, 24 weeks

• Modified Rodnan Skin Score(MRSS)

  12 weeks, 24 weeks

Study Arms (3)

hMSCs 5.0×10^7

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）5.0×10\^7 cells

Biological: MSC

hMSCs 10.0×10^7

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）10.0×10\^7 cells

Biological: MSC

hMSCs 20.0×10^7

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells（hMSCs）20.0×10\^7 cells

Biological: MSC

Interventions

MSC BIOLOGICAL

a single injection dose i.v.

hMSCs 10.0×10^7; hMSCs 20.0×10^7; hMSCs 5.0×10^7

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes, aged 18-80 years;
• SSc diagnosed according to the 2013 American College of Rheumatology and European League Against Rheumatism (ACR/EULA) criteria:
• Pulmonary fibrosis ≥10% was confirmed by high-resolution chest computed tomography (HRCT);
• The diffusion capacity for carbon monoxide (DLco) was 30%-89% of the expected value, and progression of interstitial lung disease was found. Progression was confirmed if one of the following criteria was met:
• A decline of 10% or more in the percentage of predicted forced vital capacity (FVC%p) within 24 months (significant decline in ventilatory function) despite treatment;
• A decline of ≥5% in FVC%p + a decline of ≥15% in DLco (a decline in ventilation function + a decline in diffusion capacity) within 24 months despite treatment;
• Within 24 months, high resolution CT (HRCT) showed worsening of pulmonary fibrosis + ≥5% decline in FVC%p (deterioration of lung imaging + decline in ventilatory function), despite treatment.
• Despite the treatment, 24 months reduced FVC % p + 5% or higher clinical symptoms (reduced ventilation function + symptoms);
• Worsening of pulmonary fibrosis on HRCT + worsening of clinical symptoms (worsening of lung imaging + worsening of symptoms) within 24 months despite treatment;
• Forced Vital Capacity (FVC) was greater than 40% of expected vital capacity;
• The patient was able to complete the 6-Minute Walk Test (6MWT);
• Be able to understand and complete pulmonary function test procedures.
• Fully informed experiment purposes, methods, and possible uncomfortable, willing to medicine and follow-up inspection on time, according to the requirements of plan agreed to participate in trials, and sign the informed consent.

You may not qualify if:

• The patients were diagnosed with other lung diseases other than SSc-ILD, such as COPD, lung abscess, lung cancer and other types of connective tissue disease-related interstitial lung disease.
• Have obvious acute lung infection requiring anti-infection treatment (treatment of 4 weeks prior to the start of the respiratory tract infection and systemic infection);
• History of severe pulmonary hypertension, including right heart failure, cardiac intubation, and parenteral administration of prostaglandin analogues;
• History of myocardial infarction or angina pectoris within 6 months before enrollment;
• Patients with 3 or more fingertip ulcers when signing the informed consent form or unable to accurately observe fingertip ulcers due to other reasons of the hand;
• Allergic to any component of the medication;
• Life expectancy of less than 1 year due to diseases other than SSc;
• Planned surgical procedures during the trial;
• Has a history of scleroderma kidney crisis;
• Patients who had used glucocorticoids within 2 weeks before enrollment but could not maintain the dosage ≤10mg/ d equivalent prednisone;
• Patients who had used methotrexate within 2 months before enrollment, or failed to maintain a stable dosage while using other immunosuppressants;
• Into groups of 2 months before used anti fibrosis drug (such as pyrazole ketone, dani, cloth, etc.);
• Patients treated with rituximab, tocilizumab and mesenchymal stem cells within 2 months before enrollment;
• Patients with other systemic diseases and organ dysfunction (ALT\>1.5 times upper limit of normal; Cr\>1.5 times upper limit of normal; LVEF≤40%; Other progressive or uncontrolled diseases);
• Active hepatitis, tuberculosis, HIV infection;

Sponsors & Collaborators

• Shanghai IxCell Biotechnology Co., LTD: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

Location

Study Officials

• tao Ren, Doctor

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

tao Ren, Doctor

CONTACT

021-64369181; rentao305@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)